Back to resultsSafety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate
Amprenavir
Efavirenz
Adefovir dipivoxil
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Had an HIV level of at least 2,000 copies/ml after 6 months of treatment with at least 1 PI other than amprenavir (meaning you failed PI treatment). Are at least 13 years old (need consent of parent or guardian if under 18). Are able to complete the study. Agree to use effective barrier methods of birth control, such as condoms, during the study. Exclusion Criteria You will not be eligible for this study if you: Have certain serious medical conditions, including AIDS-related cancers (except Kaposi's sarcoma) that require treatment during the study. Have ever taken or are allergic to adefovir dipivoxil, ABC, APV, EFV. Are participating in another anti-HIV drug trial during this study. Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system. Have been diagnosed with hepatitis within the past 30 days. Abuse alcohol or drugs. Are pregnant or breast-feeding. Have ever taken NNRTIs. Have ever taken ddI or d4T. Have received chemotherapy or radiation therapy within 30 days prior to study entry.
Sites / Locations
- Pacific Oaks Med Group
- Univ of Colorado / Health Science Ctr
- AIDS Research Consortium of Atlanta
- Brown Univ School of Medicine
- Hampton Roads Med Specialists
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002419
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
Collaborators
Glaxo Wellcome, Dupont Applied Biosciences
1. Study Identification
Unique Protocol Identification Number
NCT00002419
Brief Title
Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
Official Title
A Phase II, 24-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of Novel Quadruple-Combination Therapy With Preveon (Adefovir Dipivoxil; Bis-POM PMEA), Abacavir (1592U89), Sustiva (Efavirenz; DMP-266), and Amprenavir (141W94) for the Treatment of HIV-1 Infection in Patients Who Have Failed Previous Protease Inhibitor Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 1999
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
Collaborators
Glaxo Wellcome, Dupont Applied Biosciences
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors (PIs).
Detailed Description
Patients receive a treatment regimen of adefovir dipivoxil, abacavir, efavirenz, and amprenavir for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving the study treatment and to attend scheduled follow-up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Amprenavir
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
Are HIV-positive.
Had an HIV level of at least 2,000 copies/ml after 6 months of treatment with at least 1 PI other than amprenavir (meaning you failed PI treatment).
Are at least 13 years old (need consent of parent or guardian if under 18).
Are able to complete the study.
Agree to use effective barrier methods of birth control, such as condoms, during the study.
Exclusion Criteria
You will not be eligible for this study if you:
Have certain serious medical conditions, including AIDS-related cancers (except Kaposi's sarcoma) that require treatment during the study.
Have ever taken or are allergic to adefovir dipivoxil, ABC, APV, EFV.
Are participating in another anti-HIV drug trial during this study.
Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system.
Have been diagnosed with hepatitis within the past 30 days.
Abuse alcohol or drugs.
Are pregnant or breast-feeding.
Have ever taken NNRTIs.
Have ever taken ddI or d4T.
Have received chemotherapy or radiation therapy within 30 days prior to study entry.
Facility Information:
Facility Name
Pacific Oaks Med Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Univ of Colorado / Health Science Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Brown Univ School of Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
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